Monitoring audit report in accordance with

Transcription

1 Monitoring audit report in accordance with Directive 94/9/EC for the company Hectronic GmbH Allmendstraße 15 D Bonndorf

2 Contents 1 Audit result Scope Company description Scope of certification Changes in management system / Verification of contractual base Findings Positive findings and suggestions for improvements Dates... 7 Auditbericht-Ex Rev 6.doc (09/13) Seite 2/10

3 Lead Auditor : Dipl.-Ing. R. Biegalla Auditors : -- Employees responsible : Mr Köhntopp (ATEX), Mrs Fauser (ATEX), Mr Otteny (ISO 9001) Date of audit : Audit result The functionality of the management system was verified by a suitably selected auditor on the company premises on the basis of random checks. This applies in particular to the conformity of work processes with the norm requirements and the descriptions in the management system documentation. The specificities of the company s business and the applicable requirements of legislation, regulation and other higher-level documents were also taken into account. This took place by means of random sampling, including questioning and inspecting the relevant documents. The findings of the audit and suggestions for improvement are described in chapters 4 and 5 of this report. In the last audit nonconformities were identified which have been demonstrably rectified. The corrections and corrective measure carried out have been verified. The certifiability was established in the course of a Stage 1 audit. Identified weaknesses have been eliminated and evidence provided of the corrections. In the current audit nonconformities have been identified: Standard(s): Directive 94/9/EC No. Due to serious nonconformities (No. X) with individual norm requirements a follow-up audit is required to verify the corrections and corrective measures taken (forecast date: ddmmyyyy) The organisation has established and implemented an effective system to achieve its policies and goals. X In accordance with the objectives of the audit the auditor confirms that the organisation's management system meets the requirements of the standard(s) and is maintained and implemented adequately. The auditor therefore recommends (on condition that the corrections and corrective measures taken to rectify the identified nonconformities are verified): X That the new certificates are issued. That the existing certification is maintained. That the changes (see chapter 3) should be included in the scope of the existing certification. That the certificates are maintained or issued once the follow-up audit has been carried out successfully. 2 Scope 2.1 Company description The scope and the quality aspects have not changed since the previous audit. Auditbericht-Ex Rev 6.doc (09/13) Seite 3/10

4 The company still has around 142 employees, of which around 16 employees are responsible for ATEX products. 2.2 Scope of certification Scope of certification: (for each standard) Norm chapters excluded from Directive 94/9/EC 7.3 Development Reason for exclusion: Not applicable under DIN EN ISO/IEC :2012 Locations covered by scope of certification: Location No Locations covered by the certification Name / Postal address 01 Hectronic GmbH Allmendstr. 15 D Bonndorf Scope of processes 142 see above Production, final equipment inspection and testing of sensors and evaluation devices for measurement and control technique and inductive detection systems Number of employ ployees Audited X The audit base for the Directive was as follows: ISO 9001:2008 IECEx-Scheme IEC Directive 94/9/EC Annexe IV Part 1: Principles EN :2012+A11;2013 EN Principles and methodology (EN Principles and methodology in mines) Intrinisic safety Ex i EN :2012 Equipment with equipment protection level (EPL) Ga Ga EN :2007 In conjunction with the following EC-Type Examination Certificates: On Mr Köhntopp has conducted a risk assessment for the updated standard :2012 to replace the type of protection EN :2007. This applies to following EC-type examination certificates: TÜV 98 ATEX 1354 SEV 10 ATEX 0104X TÜV 98 ATEX 1382 SEV 09 ATEX 0109 SEV 05 ATEX 0116X Auditbericht-Ex Rev 6.doc (09/13) Seite 4/10

5 ATEX Fuel pump type series HECPUMP LOM 14 ATEX 2037 with 1 st ( ) addition OPTILEVEL Supply resp. OPTILEVEL Supply TA Level control device Type NK 31 Hecofill xx xxxx-xx Fuel level sensor Type HLS 6010 / HLS 6010 RF PetroPoint Nozzle Unit / Vehicle TAG`s Fuel level sensor Inovo Level Probe IECEx: Vehicle recognition system TÜV 98 ATEX 1382 with 1 st - 4 th addition ( ) TÜV 98 ATEX 1354 with 1 st - 3 rd addition ( ) there will be a new development SEV 05 ATEX 0116 X with 1 st - 2 nd addition ( ) SEV 09 ATEX 0109 with 1 st - 2 nd addition ( ) SEV 10 ATEX 0104X with 1 st ( ) addition applied addition SEV 15 ATEX 0119 ( , not in production yet, expected start of production 12/2015) IECEx SEV X with 1 st ( ), addition applied Vehicle recognition system ANZEEx X Level Sensor HLS 6010, HLS 6010 RF OPTILEVEL Supply resp. OPTILEVEL Supply TA Level Probe Type: Inovo Level Probe IECEx SEV with 1 st addition ( ) IECEx TUN with 2 nd addition ( ) addition IECEx SEV with 1 st addition ( , not in production yet, expected start of production 12/2015 ) 3 Changes in management system / Verification of contractual base No significant changes have been made to the management system or the management system documentation since the last audit. The data on which the audit commission is based (e.g. number of employees, scope and premises) correspond to the actual situation at the company). The monitoring audit ISO 9001 took place at the same time as the audit under Directive 94/9/EC. There were no nonconformities. 4 Findings The findings of the audit in accordance with the audited standards are listed in the annexes to this report (see Annexe). Auditbericht-Ex Rev 6.doc (09/13) Seite 5/10

6 All the information obtained in the course of the audit will be treated in strict confidence by the auditor and the certification body. In view of the random sampling on which the audit is based it should be noted that weaknesses and nonconformities may exist which were not identified in the course of the audit. 4.1 Positive findings and suggestions for improvements No Segment/ Department/ Site Positive findings 1 General A new EC-type examination certificate SEV 15 ATEX 0119 was gained for the discontinued EC-type examination certificate SEV 09 ATEX ATEX officer ATEX officer Mr Köhntopp left the company on The new person in charge is Mrs Fauser, who has been instructed since April The following recommendations and suggestions from the auditor are intended to contribute to the permanent improvement of the management system. No Segment/ Department/ Site Recommendations and suggestions for improvement 1 ATEX officer The appointment of Ms Fauser as ATEX officer still needs to be finalised by the management. Appropriate job description and inclusion in the organisational chart. 2 Production refuelling Sensor technology Explosion protection training has already been planned and needs to be performed and verified. The documentation of the final inspection should be visible in the device certificate, for example by stating the inspection plan number. Example: Inspection plan no for EC type examination certificate LOM 14 ATEX 2037 or inspection plan no.: for EC type examination certificate SEV 05 ATEX 0116X. 3 Repair Center The VA R2.1 with regard to the automatic acknowledgement of receipts as well as the document storage in DMS is currently being revised. The following points must be considered additionally in the revision: Person responsible for the process Decision whether a new final inspection with regard to the ATEX regulations is necessary after the relevant test instruction 4 ATEX officer The audit reports of the supplier audits at Impro and InterCard still refer to EN ATEX officer In future, the audit reports of the supplier audits should include the documentation statuses as actual/target comparisons for e.g. production drawings etc. 6 QMB/ATEX officer As Ms Fauser will also perform the supplier audits in the future, the QMB should assist with the first audits. 7 QMB/ATEX officer All ATEX products should be audited in regular intervals in the internal ATEX products audits. Auditbericht-Ex Rev 6.doc (09/13) Seite 6/10

7 5. Dates Due Date of next Audit 31 st Juli 2016 Agreed date of next Audit 21 st - 22 th June Date Lead Auditor Auditbericht-Ex Rev 6.doc (09/13) Seite 7/10

8 Annex RL 94/9/EG Item Policy / Goals Process control including outsourced processes Audit result Company management has declared its quality policy to be binding and has implemented it. The quality policy is appropriate and provides a framework for the individual quality goals. It obliges all employees to permanent improvement of the quality management system. The main quality goals for the Directive 94/9/EC are: Customer satisfaction New customer acquisition Stabilisation of quality performance indicators Strengthen sales Complaints management Others are described below in the 2012 company goals The existing processes in the company were identified and specified. Their sequence and interaction are shown, they are guided accordingly. The processes are regularly assessed by means of specified key figures. The main processes are: Assembly Moulding Soldering Incoming goods inspection / final inspection Customer-specific and other requirements The following processes are outsourced: Production of the PetroPoint nozzle unit, EC-BMP SEV 10 ATEX 0104 X in South Africa at Impro Technologies (Pty) Ltd. An initial assessment was conducted by Mr Köhntopp on site in % of the components are put into circulation from Bonndorf. Regular supplier audits are performed by Mr Köhntopp. The last supplier audit was performed The ATEX officer did not detect any deviations. The next audit is scheduled for November Manufacture of the level sensor Hecofill EC-BMP SEV 05 ATEX 0116 X by Inter- Card GmbH in Bad Dürrheim and BR-Elektronik GmbH (moulding). An initial assessment was conducted by Mr Köhntopp on site in Regular supplier audits are performed by Mr Köhntopp. The ATEX officer did not detect any deviations. The last supplier audit was performed on The control and inspection of these processes is appropriate. Customer requirements and requests as well as documented, conditional, statutory and regulatory requirements are analysed and evaluated in the team as part of a manufacturing and feasibility study. Offers are prepared and approved. Agreement between the offer and the order is verified by the person who prepared the offer and documented by means of an order confirmation. The same rules apply to amendments. The following process standards have a significant effect on product quality: Incoming goods control Auditbericht-Ex Rev 6.doc (09/13) Seite 8/10

9 Item Audit result Interim checks Final inspection The main statutory, regulatory and customer standards are: German Industrial Safety Ordinance Directive 94/9/EC Health and safety at work regulations EMC Directive 2004/108/EC Low Voltage Directive 2006/95/EC Machinery Directive 2006/42/EC Measuring Instruments Directive 2004/22/EC Customer satisfaction and complaints Internal audit and management review The processes on dealing with information, data analyses, improvements and reactions to customer comments have been defined and are effective. The implementation, maintenance and efficiency of the MS is measured by means of annually planned product audits. The following product audits were performed: Optilevel Supply with SN on FDA Sensor with SN and SN on Level controller with SN on Use of certificate and logo No deviations were detected. The audits in the company are performed reliably. The detected internal deviations were rectified by the time of this documented audit. The company management regularly and appropriately assesses the quality management system in order to ensure its continued suitability, adequacy and effectiveness. The management assessment of was performed appropriately and effectively in all points. The use of logo and certificate (e.g. on business cards, company brochures, internet etc) is adequate. Standard requirement Assessment * Standard requirement Assessment * No of nonconformity * Assessment: 1 = Satisfactory 2 = Satisfactory with potential for improvement 3 = Unsatisfactory/Nonconformity (see Nonconformity report) Auditbericht-Ex Rev 6.doc (09/13) Seite 9/10

10 4 = Not applicable 5 = Not audited in this audit Auditbericht-Ex Rev 6.doc (09/13) Seite 10/10